Category Archives: PolarityTE

PolarityTE and its Hairy Tease

PolarityTE Logo

I first covered hairy skin regeneration company PolarityTE (PTE) in 2017. I did not update their work for two years as their were some concerns. However, it seems like the company is still active and holds potential. So it is time for an update.

Update: June 2021

SkinTE Biologics License Application

PolarityTE plans to file for a Biologics License Application (BLA) for SkinTE in the second half of 2021. In the meantime, the company will (temporarily) cease sales of SkinTE and wind down commercial operations.

Note that this issue is related to the US FDA’s recent announcement that enforcement discretion related to 361 HCT/P products will not be extended beyond May 31, 2021. A development that has also adversely impacted the marketing and use of exosomes in hair loss patients.

Despite a limited team of just eight sales agents, PolarityTE reported record SkinTE sales of $1.73 million in the first quarter of 2021. Per CEO David Seaburg, the company will still try to help physicians who are treating severe wounds in patients through compassionate use programs. Possibility via the FDA’s Expanded Access IND program.

So all in all, it seems like SkinTE is at least a modest success. Future sales will depend on the BLA approval. Note that in May 2021, PolarityTE announced positive results in initial trials of using SkinTE to treat diabetic foot ulcers.

May 1, 2019

My past posts on skin regeneration company PolarityTE are worth a reread for background information. The only reason I keep covering this Utah-based company is because the new skin they claim to be able to regenerate includes new hair follicles. The company is also led by some highly reputable and experienced scientists.

In the past, PolarityTE even had a photo of a balding man on their site getting treatment on his scalp. Although this photo has since disappeared, we all hope that the company can regrow scalp hair by regrowing scalp skin.

PolarityTE and Hair Follicles

In March, scientists from PolarityTE in collaboration with others published an important new study: In vivo expansion and regeneration of full‐thickness functional skin. The below caught my eye:

PolarityTE Hair and Skin.

Moreover, in a recent Australian radio interview, PolarityTE’s (now ex) CEO Dr. Denver Lough said the following:

PolarityTE CEO Denver Lough Interview.

All of this is very encouraging. Skin regeneration is a far greater area of research than hair regeneration, since burn and accident victims can become irreparably disfigured.

PolarityTE Fights Back

PolarityTE Logo

PolarityTE is an interesting new skin (and potentially hair) regeneration company that I have covered on this blog several times during the past year. My main reason for taking the company seriously has been due to its highly experienced staff (including doctors, surgeons and research scientists).

Moreover, a few months ago, they even showed an image of a balding scalp regrowing some hair on their website. This has since been removed, but I discussed it in the bottom half of this post.

PolarityTE’s main product is known as SkinTE, which supposedly grows new hair-bearing skin. According to the company:

“SkinTE has resulted in regenerative full-thickness healing of skin with all its layers (epidermis, dermis and hypodermis) and its appendages (hair follicles, glands, etc.).”

PolarityTE Responds to Citron Research

On September 18th, PolarityTE’s stock market ticker symbol was changed from “COOL” to “PTE” (Update: No longer valid).

Earlier this week, Citron Research published a highly critical article about PTE on its home page. This article remains there as of today, and is described as being “what might (be) our shortest but most damaging report to date”.

Several of the conclusions are pretty wild, with the below being being the most striking:

“And we believe the stock is a ZERO.”

Although the title of the Citron article is:

“PolarityTE: This Game Is Over! Price Target — $2”

So maybe not ZERO?

Several days ago, PolarityTE decided to respond to all these allegations on their website. They accuse Citron Research of being a tool used by “notorious short sellers”. They also criticize the founder of Citron.

Citron’s founder, Andrew Left, supposedly focuses his coverage on companies that he believes are overvalued or are engaging in fraud. There has also been some unusual trading activity around PTE in recent weeks.

I know that many of this blog’s readers purchase stocks in hair loss related companies. I would be very cautious about all companies involved in this sector. Especially when it comes to newer start-ups that largely rely on one or two products and their future potential.

In related news:

  • Restoration Robotics (HAIR) stock is down 75 percent in the past year. The company makes the renowned ARTAS robotic hair transplantation system. Maybe this lawsuit is partly to blame?
  • Aclaris Therapeutics (ACRS) stock is down over 50 percent during the past year.